Recall Z-0931-2021— K2M, Inc
Class II · Terminated
Class II FDA medical device recall by K2M, Inc, initiated 2020-12-14, terminated 2023-07-11. It names one FDA 510(k) clearance: K171444. Product: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System. Reason: The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length)..
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-14
- Terminated
- 2023-07-11
- Firm location
- Leesburg, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Reason for recall
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Data sourced from openFDA. This site is unofficial and independent of the FDA.